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Human Subjects

The Human Subjects Committee (also known as the Institutional Review Board or IRB) assures that risks to human research subjects are minimized, consent is voluntary and informed and confidentiality is protected. The Committee upholds the principles articulated in the Belmont Report and applies the regulations articulated in the Common Rule.

To determine if your study/research/project requires Committee review, go to QuestionPro and answer a few targeted questions.

If you plan to collect data from SDSU students, please bear in mind that the University will not send a mass email to all students for a research project. Groups of students may be contacted on an investigator’s behalf through the following channels:

  • The Student Association can post links to surveys in the Jackrabbit Report or on MyState.
  • Faculty members can email students in their classes.
  • Coaches can email student athletes.
  • Department heads can email students in their departments.
  • Deans can email students in their college.

Training:

All researchers conducting human subjects research are required to complete training in the protection of human research participants found at www.citiprogram.org.

Submitting a proposal:

Any research project in which University faculty, staff or students will collect and analyze data on human subjects must be reviewed and approved by the IRB before data collection begins. To submit a proposal:

  • First complete the online Human Subject Research Application Form and print it as a PDF.
  • Next, go to InfoReady, SDSU’s internal submission platform, click Apply and log in with your SDSU credentials. 
  • Fill out the basic information screen, upload the completed application form and all relevant attachments (such as consent forms, survey instrument, etc.).
  • To finalize your application, accept the certification statement and click the Submit button.

Amendments to approved proposals should also be submitted via InfoReady.

Reporting a problem:

Researchers must report any incident that is unexpected (given the research procedures and population), may have been caused by the procedures involved in the research, and suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic or social harm) than was previously known or recognized. In addition to adverse events/effects, you should also report any breaches of confidentiality and complaints about the study from subjects or staff.

If any such problem occurs, please take the following action:

  1. Attend to the safety and care of the research participant.
  2. Consider whether any more participants should be used in the research and consider immediately stopping the study until the occurrence is investigated.
  3. If the problem is serious (harmful, fatal or life threatening), report the event either orally or in writing to the Research Integrity and Compliance Officer within three days. 605-688-5051

For all problems, submit the Unanticipated/Serious Problem Reporting Form on InfoReady within ten working days. The Research Integrity and Compliance Officer will review the report to follow up and take appropriate action.